Publications by authors named "Peter Bower"

298 Publications

Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice.

Cochrane Database Syst Rev 2021 Oct 12;10:CD011589. Epub 2021 Oct 12.

Health Services & Policy Research, Exeter Collaboration for Academic Primary Care (APEx), NIHR School for Primary Care Research, NIHR ARC South West Peninsula (PenARC), University of Exeter, Exeter, UK.

Background: Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback  on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback.

Objectives: To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care.

Search Methods: We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field.

Selection Criteria: Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information.

Data Collection And Analysis: Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible.

Main Results: We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion.

Authors' Conclusions: PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether   many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD011589.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509115PMC
October 2021

Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.

BMC Med 2021 09 23;19(1):218. Epub 2021 Sep 23.

Department of Psychology, University of Bath, Bath, BA2 7AY, UK.

Background: The information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded 'studies within a trial' (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment.

Methods: Seven 'host' trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part.

Results: Six SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I = 0%).

Conclusions: Participant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies.

Trial Registration: Healthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12916-021-02086-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8459527PMC
September 2021

Identifying older adults with frailty approaching end-of-life: A systematic review.

Palliat Med 2021 Sep 14:2692163211045917. Epub 2021 Sep 14.

National Institute for Health Research (NIHR) Older People and Frailty Policy Research Unit, Population Health Sciences Institute, Newcastle University, Newcastle-upon-Tyne, UK.

Background: People with frailty may have specific needs for end-of-life care, but there is no consensus on how to identify these people in a timely way, or whether they will benefit from intervention.

Aim: To synthesise evidence on identification of older people with frailty approaching end-of-life, and whether associated intervention improves outcomes.

Design: Systematic review (PROSPERO: CRD42020462624).

Data Sources: Six databases were searched, with no date restrictions, for articles reporting prognostic or intervention studies. Key inclusion criteria were adults aged 65 and over, identified as frail via an established measure. End-of-life was defined as the final 12 months. Key exclusion criteria were proxy definitions of frailty, or studies involving people with cancer, even if also frail.

Results: Three articles met the inclusion criteria. Strongest evidence came from one study in English primary care, which showed distinct trajectories in electronic Frailty Index scores in the last 12 months of life, associated with increased risk of death. We found no studies evaluating established clinical tools (e.g. Gold Standards Framework) with existing frail populations. We found no intervention studies; the literature on advance care planning with people with frailty has relied on proxy definitions of frailty.

Conclusion: Clear implications for policy and practice are hindered by the lack of studies using an established approach to assessing frailty. Future end-of-life research needs to use explicit approaches to the measurement and reporting of frailty, and address the evidence gap on interventions. A focus on models of care that incorporate a palliative approach is essential.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/02692163211045917DOI Listing
September 2021

Rates of turnover among general practitioners: a retrospective study of all English general practices between 2007 and 2019.

BMJ Open 2021 08 22;11(8):e049827. Epub 2021 Aug 22.

Division of Informatics, Imaging & Data Sciences, School of Health Sciences, The University of Manchester, Manchester, UK

Objective: To quantify general practitioners' (GPs') turnover in England between 2007 and 2019, describe trends over time, regional differences and associations with social deprivation or other practice characteristics.

Design: A retrospective study of annual cross-sectional data.

Setting: All general practices in England (8085 in 2007, 6598 in 2019).

Methods: We calculated turnover rates, defined as the proportion of GPs leaving a practice. Rates and their median, 25th and 75th percentiles were calculated by year and region. The proportion of practices with persistent high turnover (>10%) over consecutive years were also calculated. A negative binomial regression model assessed the association between turnover and social deprivation or other practice characteristics.

Results: Turnover rates increased over time. The 75th percentile in 2009 was 11%, but increased to 14% in 2019. The highest turnover rate was observed in 2013-2014, corresponding to the 75th percentile of 18.2%. Over time, regions experienced increases in turnover rates, although it varied across English regions. The proportion of practices with high (10% to 40%) turnover within a year almost doubled from 14% in 2009 to 27% in 2019. A rise in the number of practices with persistent high turnover (>10%) for at least three consecutive years was also observed, from 2.7% (2.3%-3.1%) in 2007 to 6.3% (5.7%-6.9%) in 2017. The statistical analyses revealed that practice-area deprivation was moderately associated with turnover rate, with practices in the most deprived area having higher turnover rates compared with practices in the least deprived areas (incidence rate ratios 1.09; 95% CI 1.06 to 1.13).

Conclusions: GP turnover has increased in the last decade nationally, with regional variability. Greater attention to GP turnover is needed, in the most deprived areas in particular, where GPs often need to deal with more complex health needs. There is a large cost associated with GP turnover and practices with very high persistent turnover need to be further researched, and the causes behind this identified, to allow support strategies and policies to be developed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2021-049827DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8362689PMC
August 2021

Interventions Using Wearable Physical Activity Trackers Among Adults With Cardiometabolic Conditions: A Systematic Review and Meta-analysis.

JAMA Netw Open 2021 Jul 1;4(7):e2116382. Epub 2021 Jul 1.

National Institute for Health Research, School for Primary Care Research, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom.

Importance: Wearable physical activity (PA) trackers, such as accelerometers, fitness trackers, and pedometers, are accessible technologies that may encourage increased PA levels in line with current recommendations. However, whether their use is associated with improvements in PA levels in participants who experience 1 or more cardiometabolic conditions, such as diabetes, prediabetes, obesity, and cardiovascular disease, is unknown.

Objective: To assess the association of interventions using wearable PA trackers (accelerometers, fitness trackers, and pedometers) with PA levels and other health outcomes in adults with cardiometabolic conditions.

Data Sources: For this systematic review and meta-analysis, searches of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and PsycINFO were performed from January 1, 2000, until December 31, 2020, with no language restriction. A combination of Medical Subject Heading terms and text words of diabetes, obesity, cardiovascular disease, pedometers, accelerometers, and Fitbits were used.

Study Selection: Randomized clinical trials or cluster randomized clinical trials that evaluated the use of wearable PA trackers, such as pedometers, accelerometers, or fitness trackers, were included. Trials were excluded if they assessed the trackers only as measuring tools of PA before and after another intervention, they required participants to be hospitalized, assessors were not blinded to the trackers, or they used a tracker to measure the effect of a pharmacological treatment on PA among individuals.

Data Extraction And Synthesis: The study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. A random-effects model was used for the meta-analysis.

Main Outcomes And Measures: The primary outcome was mean difference in PA levels. When the scale was different across studies, standardized mean differences were calculated. Heterogeneity was quantified using the I2 statistic and explored using mixed-effects metaregression.

Results: A total of 38 randomized clinical trials with 4203 participants were eligible in the systematic review; 29 trials evaluated pedometers, and 9 evaluated accelerometers or fitness trackers. Four studies did not provide amenable outcome data, leaving 34 trials (3793 participants) for the meta-analysis. Intervention vs comparator analysis showed a significant association of wearable tracker use with increased PA levels overall (standardized mean difference, 0.72; 95% CI, 0.46-0.97; I2 = 88%; 95% CI, 84.3%-90.8%; P < .001) in studies with short to medium follow-up for median of 15 (range, 12-52) weeks. Multivariable metaregression showed an association between increased PA levels and interventions that involved face-to-face consultations with facilitators (23 studies; β = -0.04; 95% CI, -0.11 to -0.01), included men (23 studies; β = 0.48; 95% CI, 0.01-0.96), and assessed pedometer-based interventions (26 studies; β = 0.20; 95% CI, 0.02-0.32).

Conclusions And Relevance: In this systematic review and meta-analysis, interventions that combined wearable activity trackers with health professional consultations were associated with significant improvements in PA levels among people with cardiometabolic conditions.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jamanetworkopen.2021.16382DOI Listing
July 2021

Person-centred experiential therapy versus cognitive behavioural therapy delivered in the English Improving Access to Psychological Therapies service for the treatment of moderate or severe depression (PRaCTICED): a pragmatic, randomised, non-inferiority trial.

Lancet Psychiatry 2021 06 14;8(6):487-499. Epub 2021 May 14.

School of Health and Related Research, University of Sheffield, Sheffield, UK.

Background: The UK Government's implementation in 2008 of the Improving Access to Psychological Therapies (IAPT) initiative in England has hugely increased the availability of cognitive behavioural therapy (CBT) for the treatment of depression and anxiety in primary care. Counselling for depression-a form of person-centred experiential therapy (PCET)-has since been included as an IAPT-approved therapy, but there is no evidence of its efficacy from randomised controlled trials (RCTs), as required for recommendations by the National Institute for Health and Care Excellence. Therefore, we aimed to examine whether PCET is cost effective and non-inferior to CBT in the treatment of moderate and severe depression within the IAPT service.

Methods: This pragmatic, randomised, non-inferiority trial was done in the Sheffield IAPT service in England and recruited participants aged 18 years or older with moderate or severe depression on the Clinical Interview Schedule-Revised. We excluded participants presenting with an organic condition, a previous diagnosis of personality disorder, bipolar disorder, or schizophrenia, drug or alcohol dependency, an elevated clinical risk of suicide, or a long-term physical condition. Eligible participants were randomly assigned (1:1), independently of the research team, and stratified by site with permuted block sizes of two, four, or six, to receive either PCET or CBT by use of a remote, web-based system that revealed therapy after patient details were entered. Those assessing outcomes were masked to treatment allocation. Participants were seen by appropriately trained PCET counsellors and CBT therapists in accordance with the IAPT service delivery model. Depression severity and symptomatology measured by the Patient Health Questionnaire-9 (PHQ-9) at 6 months post-randomisation was the primary outcome, with the PHQ-9 score at 12 months post-randomisation being a key secondary outcome. These outcomes were analysed in the modified intention-to-treat population, which comprised all randomly assigned patients with complete data, and the per-protocol population, which comprised all participants who did not switch from their randomised treatment and received between four and 20 sessions. Safety was analysed in all randomly assigned patients. The non-inferiority margin was set a priori at 2 PHQ-9 points. Patient safety was monitored throughout the course of therapy, adhering to service risk procedures for monitoring serious adverse events. This trial is registered at the ISRCTN Registry, ISRCTN06461651, and is complete.

Findings: From Nov 11, 2014, to Aug 3, 2018, 9898 patients were referred to step three treatments in the Sheffield IAPT service for common mental health problems, of whom 761 (7·7%) were referred to the trial. Of these, we recruited and randomly assigned 510 participants to receive either PCET (n=254) or CBT (n=256). In the PCET group, 138 (54%) participants were female and 116 (46%) were male, and 225 (89%) were White, 16 (6%) were non-White, and 13 (5%) had missing ethnicity data. In the CBT group, 155 (61%) participants were female and 101 (39%) were male, and 226 (88%) were White, 17 (7%) were non-White, and 13 (5%) had missing ethnicity data. The 6-month modified intention-to-treat analysis comprised 401 (79%) of the enrolled participants (201 in the PCET group; 200 in the CBT group) and the 12-month modified intention-to-treat analysis comprised 319 participants (167 in the PCET group; 152 in the CBT group). The 6-month per-protocol analysis comprised 298 participants (154 in the PCET group; 144 in the CBT group). At 6 months post-randomisation, PCET was non-inferior to CBT in the intention-to-treat population (mean PHQ-9 score 12·74 [SD 6·54] in the PCET group and 13·25 [6·35] in the CBT group; adjusted mean difference -0·35 [95% CI -1·53 to 0·84]) and in the per-protocol population (12·73 [SD 6·57] in the PCET group and 12·71 [6·33] in the CBT group; 0·27 [95% CI -1·08 to 1·62]). At 12 months post-randomisation, there was a significant adjusted between-group difference in mean PHQ-9 score in favour of CBT (1·73 [95% CI 0·26-3·19]), with a 95% CI exceeding the 2-point non-inferiority margin. There were two deaths, one death by suicide in the PCET group and one due to chronic obstructive pulmonary disease in the CBT group. Both were assessed by the responsible clinician to be unrelated to the trial. In terms of using emergency departments for depression-related events, four people (three in the PCET group; one in the CBT group) made more than a single use and six people (three in the PCET group; three in the CBT group) made a single use. One patient in the PCET group had inpatient treatment for a depression-related event.

Interpretation: This trial is the first to examine the two most frequently administered psychological therapies in the IAPT service. The finding of non-inferiority of PCET to CBT at 6 months supports the results from large, routine, non-randomised datasets from the IAPT programme. Given the high demand for psychological therapies and the need for patient choice, our findings suggest the need for continued investment in the training and delivery of PCET for improving short-term outcomes, but suggest that PCET might be inferior to CBT at 12 months.

Funding: British Association for Counselling and Psychotherapy Research Foundation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S2215-0366(21)00083-3DOI Listing
June 2021

Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve.

Trials 2021 May 10;22(1):337. Epub 2021 May 10.

NIHR Newcastle Biomedical Research Centre, Campus for Ageing and Vitality, Newcastle University and Newcastle upon Tyne NHS Trust, Newcastle, NE4 5PL, UK.

Background: Ensuring that a trial is designed so that its participants reflect those who might benefit from the results, or be spared harms, is key to the potential benefits of the trial reaching all they should. This paper describes the process, facilitated by Trial Forge, that was used between July 2019 and October 2020 to develop the INCLUDE Ethnicity Framework, part of the wider INCLUDE initiative from the National Institute for Health Research to improve inclusion of under-served groups in clinical research studies.

Methods: Development of the Framework was done in seven phases: (1) outline, (2) initial draft, (3) stakeholder meeting, (4) modify draft, (5) Stakeholder feedback, (6) applying the Framework and (7) packaging. Phases 2 and 3 were face-to-face meetings. Consultation with stakeholders was iterative, especially phases 4 to 6. Movement to the next phase was done once all or most stakeholders were comfortable with the results of the current phase. When there was a version of the Framework that could be considered final, the Framework was applied to six trials to create a set of examples (phase 6). Finally, the Framework, guidance and examples were packaged ready for dissemination (phase 7).

Results: A total of 40 people from stakeholder groups including patient and public partners, clinicians, funders, academics working with various ethnic groups, trial managers and methodologists contributed to the seven phases of development. The Framework comprises two parts. The first part is a list of four key questions: 1. Who should my trial apply to? 2. Are the groups identified likely to respond in different ways? 3. Will my study intervention make it harder for some groups to engage? 4. Will the way I have designed the study make it harder for some groups to engage? The second part is a set of worksheets to help trial teams address these questions. The Framework can be used for any stage of trial, for a healthcare intervention in any disease area. The Framework was launched on 1st October 2020 and is available open access at the Trial Forge website: https://www.trialforge.org/trial-forge-centre/include/ .

Conclusion: Thinking about the number of people in our trials is not enough: we need to start thinking more carefully about who our participants are.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13063-021-05276-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8108025PMC
May 2021

Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve.

Trials 2021 May 10;22(1):337. Epub 2021 May 10.

NIHR Newcastle Biomedical Research Centre, Campus for Ageing and Vitality, Newcastle University and Newcastle upon Tyne NHS Trust, Newcastle, NE4 5PL, UK.

Background: Ensuring that a trial is designed so that its participants reflect those who might benefit from the results, or be spared harms, is key to the potential benefits of the trial reaching all they should. This paper describes the process, facilitated by Trial Forge, that was used between July 2019 and October 2020 to develop the INCLUDE Ethnicity Framework, part of the wider INCLUDE initiative from the National Institute for Health Research to improve inclusion of under-served groups in clinical research studies.

Methods: Development of the Framework was done in seven phases: (1) outline, (2) initial draft, (3) stakeholder meeting, (4) modify draft, (5) Stakeholder feedback, (6) applying the Framework and (7) packaging. Phases 2 and 3 were face-to-face meetings. Consultation with stakeholders was iterative, especially phases 4 to 6. Movement to the next phase was done once all or most stakeholders were comfortable with the results of the current phase. When there was a version of the Framework that could be considered final, the Framework was applied to six trials to create a set of examples (phase 6). Finally, the Framework, guidance and examples were packaged ready for dissemination (phase 7).

Results: A total of 40 people from stakeholder groups including patient and public partners, clinicians, funders, academics working with various ethnic groups, trial managers and methodologists contributed to the seven phases of development. The Framework comprises two parts. The first part is a list of four key questions: 1. Who should my trial apply to? 2. Are the groups identified likely to respond in different ways? 3. Will my study intervention make it harder for some groups to engage? 4. Will the way I have designed the study make it harder for some groups to engage? The second part is a set of worksheets to help trial teams address these questions. The Framework can be used for any stage of trial, for a healthcare intervention in any disease area. The Framework was launched on 1st October 2020 and is available open access at the Trial Forge website: https://www.trialforge.org/trial-forge-centre/include/ .

Conclusion: Thinking about the number of people in our trials is not enough: we need to start thinking more carefully about who our participants are.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13063-021-05276-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8108025PMC
May 2021

Measuring frailty in younger populations: a rapid review of evidence.

BMJ Open 2021 03 22;11(3):e047051. Epub 2021 Mar 22.

National Institute for Health Research (NIHR) Older People and Frailty Policy Research Unit, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.

Objectives: Frailty is typically assessed in older populations. Identifying frailty in adults aged under 60 years may also have value, if it supports the delivery of timely care. We sought to identify how frailty is measured in younger populations, including evidence of the impact on patient outcomes and care.

Design: A rapid review of primary studies was conducted.

Data Sources: Four databases, three sources of grey literature and reference lists of systematic reviews were searched in March 2020.

Eligibility Criteria: Eligible studies measured frailty in populations aged under 60 years using experimental or observational designs, published after 2000 in English.

Data Extraction And Synthesis: Records were screened against review criteria. Study data were extracted with 20% of records checked for accuracy by a second researcher. Data were synthesised using a narrative approach.

Results: We identified 268 studies that measured frailty in samples that included people aged under 60 years. Of these, 85 studies reported evidence about measure validity. No measures were identified that were designed and validated to identify frailty in younger groups. However, in populations that included people aged over under 60 years, cumulative deficit frailty indices, phenotype measures, the FRAIL Scale, the Liver Frailty Index and the Short Physical Performance Battery all demonstrated predictive validity for mortality and/or hospital admission. Evidence of criterion validity was rare. The extent to which measures possess validity across the younger adult age (18-59 years) spectrum was unclear. There was no evidence about the impact of measuring frailty in younger populations on patient outcomes and care.

Conclusions: Limited evidence suggests that frailty measures have predictive validity in younger populations. Further research is needed to clarify the validity of measures across the adult age spectrum, and explore the utility of measuring frailty in younger groups.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2020-047051DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986767PMC
March 2021

Why trials lose participants: A multitrial investigation of participants' perspectives using the theoretical domains framework.

J Clin Epidemiol 2021 Sep 13;137:1-13. Epub 2021 Mar 13.

Health Services Research Unit, Health Sciences Building, Foresterhill, Aberdeen AB25 2ZD, UK. Electronic address:

Objectives: To use the Theoretical Domains Framework (TDF) to identify barriers and enablers to participant retention in trials requiring questionnaire return and/or attendance at follow-up clinics.

Study Design And Setting: We invited participants (n = 607) from five pragmatic effectiveness trials, who missed at least one follow-up time point (by not returning a questionnaire and/or not attending a clinic visit), to take part in semistructured telephone interviews. The TDF informed both data collection and analysis. To establish what barriers and enablers most likely influence the target behavior the domain relevance threshold was set at >75% of participants mentioning the domain.

Results: Sixteen participants (out of 25 showing interest) were interviewed. Overall, seven theoretical domains were identified as both barriers and enablers to the target behaviors of attending clinic appointments and returning postal questionnaires. Barriers frequently reported in relation to both target behaviours stemmed from participants' knowledge, beliefs about their capabilities and the consequences of performing (or not performing) the behavior. Two domains were identified as salient for questionnaire return only: goals; and memory, attention and decision-making. Emotion was identified as relevant for clinic attendance only.

Conclusion: This is the first study informed by behavioural science to explore trial participants' accounts of trial retention. Findings will serve as a guiding framework when designing trials to limit barriers and enhance enablers of retention within clinical trials.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jclinepi.2021.03.007DOI Listing
September 2021

People's preferences for self-management support.

Health Serv Res 2021 Feb 25. Epub 2021 Feb 25.

Centre for Health Economics, University of York, York, UK.

Objective: To identify and assess the preferences of people with long-term health conditions toward generalizable characteristics of self-management support interventions, with the objective to inform the design of more person-centered support services.

Data Sources: Primary qualitative and quantitative data collected on a representative sample of individuals with at least one of the fifteen most prevalent long-term conditions in the UK.

Study Design: Targeted literature review followed by a series of one-to-one qualitative semistructured interviews and a large-scale discrete choice experiment.

Data Collection: Digital recording of one-to-one qualitative interviews, one-to-one cognitive interviews, and a series of online quantitative surveys, including two best-worst scaling and one discrete choice experiment, with individuals with long-term conditions.

Principal Findings: On average, patients preferred a self-management support intervention that (a) discusses the options available to the patient and make her choose, (b) is individual-based, (c) face to face (d) with doctor or nurse, (e) at the GP practice, (f) sessions shorter than 1 hour, and (g) occurring annually for two-third of the sample and monthly for the rest. We found heterogeneity in preferences via three latent classes, with class sizes of 41% (C1), 30% (C2), and 29% (C3). The individuals' gender [P < 0.05(C1), P < 0.01(C3)], age [P < 0.05(C1), P < 0.05(C2)], type of long-term condition [P < 0.05(C1), P < 0.01(C3)], and presence of comorbidity [P < 0.01(C1), P < 0.01(C3), P < 0.01(C3)] were able to characterize differences between these latent classes and help understand the heterogeneity of preferences toward the above mentioned features of self-management support interventions. These findings were then used to profile individuals into different preference groups, for each of whom the most desirable form of self-management support, one that was more likely to be adopted by the recipient, could be designed.

Conclusions: We identified several factors that could be used to inform a more nuanced self-management support service design and provision that take into account the recipient's characteristics and preferences.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/1475-6773.13635DOI Listing
February 2021

Is the NHS Diabetes Prevention Programme Intervention Delivered as Planned? An Observational Study of Fidelity of Intervention Delivery.

Ann Behav Med 2021 Feb 13. Epub 2021 Feb 13.

Manchester Centre of Health Psychology, Division of Psychology and Mental Health, University of Manchester, Manchester, UK.

Background: The NHS Diabetes Prevention Programme (NHS-DPP) has been delivered by four commercial organizations across England, to prevent people with impaired glucose tolerance developing Type 2 diabetes. Evidence reviews underpinning the NHS-DPP design specification identified 19 Behavior Change Techniques (BCTs) that are the intervention "active ingredients." It is important to understand the discrepancies between BCTs specified in design and BCTs actually delivered.

Purpose: To compare observed fidelity of delivery of BCTs that were delivered to (a) the NHS-DPP design specification, and (b) the programme manuals of four provider organizations.

Methods: Audio-recordings were made of complete delivery of NHS-DPP courses at eight diverse sites (two courses per provider organization). The eight courses consisted of 111 group sessions, with 409 patients and 35 facilitators. BCT Taxonomy v1 was used to reliably code the contents of NHS-DPP design specification documents, programme manuals for each provider organization, and observed NHS-DPP group sessions.

Results: The NHS-DPP design specification indicated 19 BCTs that should be delivered, whereas only seven (37%) were delivered during the programme in all eight courses. By contrast, between 70% and 89% of BCTs specified in programme manuals were delivered. There was substantial under-delivery of BCTs that were designed to improve self-regulation of behavior, for example, those involving problem solving and self-monitoring of behavior.

Conclusions: A lack of fidelity in delivery to the underlying evidence base was apparent, due to poor translation of design specification to programme manuals. By contrast, the fidelity of delivery to the programme manuals was relatively good. Future commissioning should focus on ensuring the evidence base is more accurately translated into the programme manual contents.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/abm/kaaa108DOI Listing
February 2021

Humanistic counselling plus pastoral care as usual versus pastoral care as usual for the treatment of psychological distress in adolescents in UK state schools (ETHOS): a randomised controlled trial.

Lancet Child Adolesc Health 2021 03 21;5(3):178-189. Epub 2021 Jan 21.

British Association for Counselling and Psychotherapy, St John's Business Park, Lutterworth, UK.

Background: About one in seven adolescents have a mental health disorder in England, UK. School counselling is one of the most common means of trying to address such a problem. We aimed to determine the effectiveness and cost-effectiveness of school-based humanistic counselling (SBHC) for the treatment of psychological distress in young people in England, UK.

Methods: We did a two-arm, individually randomised trial in 18 secondary state-funded schools across the Greater London area of the UK. Participants were randomly assigned (1:1) using a centrally secure randomisation procedure with random permuted blocks to either SBHC plus schools' pastoral care as usual (PCAU), or PCAU alone. Participants were pupils aged 13-16 years who had moderate-to-severe levels of emotional symptoms (measured by a score of ≥5 on the Strengths and Difficulties Questionnaire Emotional Symptoms scale) and were assessed as competent to consent to participate in the trial. Participants, providers, and assessors (who initially assessed and enrolled participants) were not masked but testers (who measured outcomes) were masked to treatment allocation. The primary outcome was psychological distress at 12 weeks (Young Person's Clinical Outcomes in Routine Evaluation measure [YP-CORE]; range 0-40), analysed on an intention-to-treat basis (with missing data imputed). Costs were assessed at 24 weeks (Client Service Receipt Inventory and service logs). The trial was registered with ISRCTN, number ISRCTN10460622.

Findings: 329 participants were recruited between Sept 29, 2016, and Feb 8, 2018, with 167 (51%) randomly assigned to SBHC plus PCAU and 162 (49%) to PCAU. 315 (96%) of 329 participants provided data at 12 weeks and scores were imputed for 14 participants (4%). At baseline, the mean YP-CORE scores were 20·86 (SD 6·38) for the SBHC plus PCAU group and 20·98 (6·41) for the PCAU group. Mean YP-CORE scores at 12 weeks were 16·41 (SD 7·59) for the SBHC plus PCAU group and 18·34 (7·84) for the PCAU group (difference 1·87, 95% CI 0·37-3·36; p=0·015), with a small effect size (0·25, 0·03-0·47). Overall costs at 24 weeks were £995·20 (SD 769·86) per pupil for the SBHC plus PCAU group and £612·89 (1224·56) for the PCAU group (unadjusted difference £382·31, 95% CI £148·18-616·44; p=0·0015). The probability of SBHC being more cost-effective reached 80% at a willingness to pay of £390 for a 1-point improvement on the YP-CORE. Five serious adverse events occurred for four participants in the SBHC plus PCAU group, all involving suicidal intent. Two serious adverse events occurred for two participants in the PCAU group, one involving suicidal intent.

Interpretation: The addition of SBHC to PCAU leads to small reductions in psychological distress, but at an additional economic cost. SBHC is a viable treatment option but there is a need for equally rigorous evaluation of alternative interventions.

Funding: This work was supported by the Economic and Social Research Council (grant reference ES/M011933/1).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S2352-4642(20)30363-1DOI Listing
March 2021

Notice of Retraction. Hodkinson et al. Accelerometer- and Pedometer-Based Physical Activity Interventions Among Adults With Cardiometabolic Conditions: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019;2(10):e1912895.

JAMA Netw Open 2020 12 1;3(12):e2032700. Epub 2020 Dec 1.

National Institute for Health Research School for Primary Care Research, Manchester Academic Health Science Centre, University of Manchester, United Kingdom.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jamanetworkopen.2020.32700DOI Listing
December 2020

Enhancing the multi-dimensional assessment of quality of life: introducing the WHOQOL-Combi.

Qual Life Res 2021 Mar 17;30(3):891-903. Epub 2020 Dec 17.

Centre for Person Centred Research, Auckland University of Technology, Auckland, New Zealand.

Introduction: We revisited the global concept of subjective quality of life (QoL) as assessed by the WHOQOL-BREF to investigate whether it could be elaborated into a conceptually more comprehensive instrument with good psychometric properties. Responding to a growing need for shorter QoL measures with broader social, spiritual and environmental contents, facets from WHOQOL international modules were examined for potential integration into the new WHOQOL-Combi.

Method: Adults over 65 years, diagnosed with one or more chronic diseases (n = 2833), completed 41 WHOQOL items during the CLASSIC survey; each item represented a WHOQOL facet. This pool of specific QoL facets contained 24 from the WHOQOL-BREF (excluding general items), and 17 from recent international WHOQOL short-form modules, selected for their generic properties. Rasch modelling reduced the final item pool when assessing the WHOQOL-Combi's conceptual structure. Comparisons are made with the WHOQOL-BREF.

Results: Modelling confirmed the tenability of a 36-item solution scored as a five-domain profile, comprised of 24 WHOQOL-BREF facets and 12 new facets from modules. Social and psychological domains were strengthened by three facets, spiritual QoL by five, and physical QoL by one. The WHOQOL-Combi showed sound model fit, excellent internal consistency (α = .95), and scores discriminated between socio-demographic categories. Concurrent validity with the EQ-5D-5L was confirmed for physical and psychological domains. Performance was similar to the WHOQOL-BREF.

Conclusion: The WHOQOL-Combi offers a contemporary, comprehensive, integrated, multi-dimensional subjective QoL instrument with enhanced evaluations of social, spiritual, psychological and physical QoL. Acceptable to older people, future research should evaluate younger age groups and other cultures.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s11136-020-02661-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7952286PMC
March 2021

'Going the distance': an independent cohort study of engagement and dropout among the first 100 000 referrals into a large-scale diabetes prevention program.

BMJ Open Diabetes Res Care 2020 12;8(2)

Centre for Biostatistics, School of Health Sciences, The University of Manchester, Manchester, UK

Introduction: Diabetes prevention programs (DPPs) are effective, in a pre-diabetic population, in reducing weight, lowering glycated hemoglobin and slowing the progression to diabetes. Little is known about the relationship between participation in DPPsand participant characteristics or service delivery. We investigated uptake and retention in England's NHS DPP, reporting on variability among patient subgroups, providers, and sites.

Research Design And Methods: This prospective cohort study included 99 473 adults with non-diabetic hyperglycemia referred to the English DPP between 2016 and 2017. The program seeks to change health behaviors by offering at least 16 hours of group education and exercise. Multilevel logistic regression models were used to analyze variation in uptake, retention, and completion.

Results: Uptake among 99 473 adults referred to the program was 56% (55 275). Among 55 275 who started the program, 34% (18 562) achieved the required dose and 22% (12 127) completed the full course. After adjustment for variation in case mix, substantial heterogeneity in uptake and retention was seen across four service providers (uptake OR 1.77 (1.33, 2.34), 4.30 (3.01, 6.15), and 1.45 (1.07, 1.97) compared with the reference provider) and between sites (uptake for typical individuals ranged from 0.32 to 0.78 across the middle 95% of sites, intraclass correlation coefficient (ICC) 0.07). Higher levels of retention and completion were seen where some out-of-hours provision was offered (retention OR 1.32 (1.25, 1.39)).

Conclusions: This study provides the first independent assessment of participation in the English DPP and the first study internationally to examine the impact of DPP service delivery on participation. When implementing a large-scale DPP, heterogeneity in service provision between different providers and sites can result in variable participation beyond that attributable to case mix, with potential consequences for effectiveness and health inequalities. Extending out-of-hours provision may improve participation in prevention programs.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjdrc-2020-001835DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7733095PMC
December 2020

The NHS Diabetes Prevention Programme: an observational study of service delivery and patient experience.

BMC Health Serv Res 2020 Nov 27;20(1):1098. Epub 2020 Nov 27.

Manchester Centre for Health Psychology, Division of Psychology and Mental Health, Univeraity of Manchester, Manchester, UK.

Background: The NHS Diabetes Prevention Programme (NHS-DPP) is a nine-month, group-based behavioural intervention for adults in England at risk of developing Type 2 diabetes. Four independent providers were commissioned to deliver versions of the NHS-DPP, in line with NHS England specifications. This observational study maps NHS-DPP delivery in routine practice against the NHS specification, and compares service delivery with observed patient experiences.

Methods: Researchers observed service delivery across eight complete NHS-DPP courses (118 sessions, median 14 sessions per course), consenting 455 participants (36 staff, 398 patients, 21 accompanying persons). Key features of NHS-DPP delivery were described using the Template for Intervention Description and Replication (TIDieR) framework. Researchers wrote detailed field notes during each session, including observations of patient experience. Field notes were content analysed; instances of positive and negative experiences were labelled and grouped into categories. Researchers used a novel method of comparing observed patient experiences to variations in programme delivery.

Results: Delivery broadly followed NHS England's specification and the plans set out by providers. Deviations included the scheduling and larger group sizes in some sessions. There was variation in the type and format of activities delivered by providers. Positive patient experiences included engagement, satisfaction with the programme, good within-group relationships and reported behavioural changes. Negative experiences included poor scheduling, large groups, and dissatisfaction with the venue. Where more interactive and visual activities were delivered in smaller groups of 10-15 people with good rapport, there were generally more instances of positive patient experiences, and where there were structural issues such as problems with the scheduling of sessions, poor venues and inadequate resources, there tended to be more negative patient experiences.

Conclusions: Addressing issues that we have identified as being linked to negative experiences with the NHS-DPP could increase uptake, reduce patient drop-out and increase the overall effectiveness of the programme. In particular, modifying structural aspects of the NHS-DPP (e.g. reliable session scheduling, reducing group sizes, enough session resources) and increasing interaction appear particularly promising for improving these outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12913-020-05951-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7694420PMC
November 2020

An intervention to improve the quality of life in children of parents with serious mental illness: the Young SMILES feasibility RCT.

Health Technol Assess 2020 11;24(59):1-136

Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.

Background: Quality of life for children and adolescents living with serious parental mental illness can be impaired, but evidence-based interventions to improve it are scarce.

Objective: Co-production of a child-centred intervention [called Young Simplifying Mental Illness plus Life Enhancement Skills (SMILES)] to improve the health-related quality of life of children and adolescents living with serious parental mental illness, and evaluating its acceptability and feasibility for delivery in NHS and community settings.

Design: Qualitative and co-production methods informed the development of the intervention (Phase I). A feasibility randomised controlled trial was designed to compare Young SMILES with treatment as usual (Phase II). Semistructured qualitative interviews were used to explore acceptability among children and adolescents living with their parents, who had serious mental illness, and their parents. A mixture of semistructured qualitative interviews and focus group research was used to examine feasibility among Young SMILES facilitators and referrers/non-referrers.

Setting: Randomisation was conducted after baseline measures were collected by the study co-ordinator, ensuring that the blinding of the statistician and research team was maintained to reduce detection bias.

Participants: Phase I: 14 children and adolescents living with serious parental mental illness, seven parents and 31 practitioners from social, educational and health-related sectors. Phase II: 40 children and adolescents living with serious parental mental illness, 33 parents, five referrers/non-referrers and 16 Young SMILES facilitators.

Intervention: Young SMILES was delivered at two sites: (1) Warrington, supported by the National Society for the Prevention of Cruelty to Children (NSPCC), and (2) Newcastle, supported by the NHS and Barnardo's. An eight-session weekly group programme was delivered, with four to six children and adolescents living with serious parental mental illness per age-appropriate group (6-11 and 12-16 years). At week 4, a five-session parallel weekly programme was offered to the parents/carers. Sessions lasted 2 hours each and focused on improving mental health literacy, child-parent communication and children's problem-solving skills.

Main Outcome Measures: Phase ll children and parents completed questionnaires at randomisation and then again at 4 and 6 months post randomisation. Quality of life was self-reported by children and proxy-reported by parents using the Paediatric Quality of Life questionnaire and KIDSCREEN. Semistructured interviews with parents ( = 14) and children ( = 17) who participated in the Young SMILES groups gathered information about their motivation to sign up to the study, their experiences of participating in the group sessions, and their perceived changes in themselves and their family members following intervention. Further interviews with individual referrers ( = 5) gathered information about challenges to recruitment and randomisation. Two focus groups ( = 16) with practitioners who facilitated the intervention explored their views of the format and content of the Young SMILES manual and their suggestions for changes.

Results: A total of 35 families were recruited: 20 were randomly allocated to Young SMILES group and 15 to treatment as usual. Of those, 28 families [15/20 (75%) in the intervention group and 13/15 (87%) in the control group] gave follow-up data at the primary end point (4 months post baseline). Participating children had high adherence to the intervention and high completion rates of the questionnaires. Children and adolescents living with their parents, who had serious mental illness, and their parents were mainly very positive and enthusiastic about Young SMILES, both of whom invoked the benefits of peer support and insight into parental difficulties. Although facilitators regarded Young SMILES as a meaningful and distinctive intervention having great potential, referrers identified several barriers to referring families to the study. One harm was reported by a parent, which was dealt with by the research team and the NSPCC in accordance with the standard operating procedures.

Limitations: The findings from our feasibility study are not sufficient to recommend a fully powered trial of Young SMILES in the near future. Although it was feasible to randomise children and adolescents living with serious parental mental illness of different ages to standardised, time-limited groups in both NHS and non-NHS settings, an intervention like Young SMILES is unlikely to address underlying core components of the vulnerability that children and adolescents living with serious parental mental illness express as a population over time.

Conclusions: Young SMILES was widely valued as unique in filling a recognised gap in need. Outcome measures in future studies of interventions for children and adolescents living with serious parental mental illness are more likely to capture change in individual risk factors for reduced quality of life by considering their unmet need, rather than on an aggregate construct of health-related quality of life overall, which may not reflect these young people's needs.

Future Work: A public health approach to intervention might be best. Most children and adolescents living with serious parental mental illness remain well most of the time, so, although their absolute risks are low across outcomes (and most will remain resilient most of the time), consistent population estimates find their relative risk to be high compared with unexposed children. A public health approach to intervention needs to be both tailored to the particular needs of children and adolescents living with serious parental mental illness and agile to these needs so that it can respond to fluctuations over time.

Trial Registration: Current Controlled Trials ISRCTN36865046.

Funding: This project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 59. See the NIHR Journals Library website for further project information.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3310/hta24590DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7701992PMC
November 2020

Preventable medication harm across health care settings: a systematic review and meta-analysis.

BMC Med 2020 11 6;18(1):313. Epub 2020 Nov 6.

National Institute for Health Research School for Primary Care Research, Centre for Primary Care and Health Services Research, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Williamson Building, Oxford Road, Manchester, M13 9PL, UK.

Background: Mitigating or reducing the risk of medication harm is a global policy priority. But evidence reflecting preventable medication harm in medical care and the factors that derive this harm remain unknown. Therefore, we aimed to quantify the prevalence, severity and type of preventable medication harm across medical care settings.

Methods: We performed a systematic review and meta-analysis of observational studies to compare the prevalence of preventable medication harm. Searches were carried out in Medline, Cochrane library, CINAHL, Embase and PsycINFO from 2000 to 27 January 2020. Data extraction and critical appraisal was undertaken by two independent reviewers. Random-effects meta-analysis was employed followed by univariable and multivariable meta-regression. Heterogeneity was quantified using the I statistic, and publication bias was evaluated.

Prospero: CRD42020164156.

Results: Of the 7780 articles, 81 studies involving 285,687 patients were included. The pooled prevalence for preventable medication harm was 3% (95% confidence interval (CI) 2 to 4%, I = 99%) and for overall medication harm was 9% (95% CI 7 to 11%, I = 99.5%) of all patient incidence records. The highest rates of preventable medication harm were seen in elderly patient care settings (11%, 95% 7 to 15%, n = 7), intensive care (7%, 4 to 12%, n = 6), highly specialised or surgical care (6%, 3 to 11%, n = 13) and emergency medicine (5%, 2 to 12%, n = 12). The proportion of mild preventable medication harm was 39% (28 to 51%, n = 20, I = 96.4%), moderate preventable harm 40% (31 to 49%, n = 22, I = 93.6%) and clinically severe or life-threatening preventable harm 26% (15 to 37%, n = 28, I = 97%). The source of the highest prevalence rates of preventable harm were at the prescribing (58%, 42 to 73%, n = 9, I = 94%) and monitoring (47%, 21 to 73%, n = 8, I = 99%) stages of medication use. Preventable harm was greatest in medicines affecting the 'central nervous system' and 'cardiovascular system'.

Conclusions: This is the largest meta-analysis to assess preventable medication harm. We conclude that around one in 30 patients are exposed to preventable medication harm in medical care, and more than a quarter of this harm is considered severe or life-threatening. Our results support the World Health Organisation's push for the detection and mitigation of medication-related harm as being a top priority, whilst highlighting other key potential targets for remedial intervention that should be a priority focus for future research.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12916-020-01774-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7646069PMC
November 2020

Correction to: Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators.

Trials 2020 Oct 8;21(1):840. Epub 2020 Oct 8.

University of York and the Hull York Medical School, York, UK.

An amendment to this paper has been published and can be accessed via the original article.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13063-020-04793-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7545888PMC
October 2020

'So just to go through the options…': patient choice in the telephone delivery of the NHS Improving Access to Psychological Therapies services.

Sociol Health Illn 2021 01 22;43(1):3-19. Epub 2020 Sep 22.

Division of Nursing, Midwifery and Social Work, School of Health Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.

This article considers patient choice in mental healthcare services, specifically the ways that choice is enabled or constrained in patient-practitioner spoken interaction. Using the method of conversation analysis (CA), we examine the language used by practitioners when presenting treatment delivery options to patients entering the NHS Improving Access to Psychological Therapies (IAPT) service. Analysis of 66 recordings of telephone-delivered IAPT assessment sessions revealed three patterns through which choice of treatment delivery mode was presented to patients: presenting a single delivery mode; incrementally presenting alternative delivery modes, in response to patient resistance; and parallel presentation of multiple delivery mode options. We show that a distinction should be made between (i) a choice to accept or reject the offer of a single option and (ii) a choice that is a selection from a range of options. We show that the three patterns identified are ordered in terms of patient-centredness and shared decision-making. Our findings contribute to sociological work on healthcare interactions that has identified variability in, and variable consequences for, the ways that patients and practitioners negotiate choice and shared decision-making. Findings are discussed in relation to tensions between the political ideology of patient choice and practical service delivery constraints.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/1467-9566.13182DOI Listing
January 2021

Epidemiology and determinants of non-diabetic hyperglycaemia and its conversion to type 2 diabetes mellitus, 2000-2015: cohort population study using UK electronic health records.

BMJ Open 2020 09 6;10(9):e040201. Epub 2020 Sep 6.

Division of Population Health,Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.

Objectives: To study the characteristics of UK individuals identified with non-diabetic hyperglycaemia (NDH) and their conversion rates to type 2 diabetes mellitus (T2DM) from 2000 to 2015, using the Clinical Practice Research Datalink.

Design: Cohort study.

Settings: UK primary Care Practices.

Participants: Electronic health records identified 14 272 participants with NDH, from 2000 to 2015.

Primary And Secondary Outcome Measures: Baseline characteristics and conversion trends from NDH to T2DM were explored. Cox proportional hazards models evaluated predictors of conversion.

Results: Crude conversion was 4% within 6 months of NDH diagnosis, 7% annually, 13% within 2 years, 17% within 3 years and 23% within 5 years. However, 1-year conversion fell from 8% in 2000 to 4% in 2014. Individuals aged 45-54 were at the highest risk of developing T2DM (HR 1.20, 95% CI 1.15 to 1.25- compared with those aged 18-44), and the risk reduced with older age. A body mass index (BMI) above 30 kg/m was strongly associated with conversion (HR 2.02, 95% CI 1.92 to 2.13-compared with those with a normal BMI). Depression (HR 1.10, 95% CI 1.07 to 1.13), smoking (HR 1.07, 95% CI 1.03 to 1.11-compared with non-smokers) or residing in the most deprived areas (HR 1.17, 95% CI 1.11 to 1.24-compared with residents of the most affluent areas) was modestly associated with conversion.

Conclusion: Although the rate of conversion from NDH to T2DM fell between 2010 and 2015, this is likely due to changes over time in the cut-off points for defining NDH, and more people of lower diabetes risk being diagnosed with NDH over time. People aged 45-54, smokers, depressed, with high BMI and more deprived are at increased risk of conversion to T2DM.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2020-040201DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7484863PMC
September 2020

Normative Estimates and Agreement Between 2 Measures of Health-Related Quality of Life in Older People With Frailty: Findings From the Community Ageing Research 75+ Cohort.

Value Health 2020 08 18;23(8):1056-1062. Epub 2020 Jul 18.

Academic Unit of Elderly Care and Rehabilitation, Bradford Institute for Health Research, Bradford Teaching Hospital NHS Foundation Trust, Bradford, Leeds Institute of Health Sciences, Leeds, England, UK.

Background: Previous studies have summarized evidence on health-related quality of life for older people, identifying a range of measures that have been validated, but have not sought to present results by degree of frailty. Furthermore, previous studies did not typically use quality-of-life measures that generate an overall health utility score. Health utility scores are a necessary component of quality-adjusted life-year calculations used to estimate the cost-effectiveness of interventions.

Methods: We calculated normative estimates in mean and standard deviation for EQ-5D-5L, short-form 36-item health questionnaire in frailty (SF-36), and short-form 6-dimension (SF-6D) for a range of established frailty models. We compared response distributions across dimensions of the measures and investigated agreement using Bland-Altman and interclass correlation techniques.

Results: The EQ-5D-5L, SF-36, and SF-6D scores decrease and their variability increases with advancing frailty. There is strong agreement between the EQ-5D-5L and SF-6D across the spectrum of frailty. Agreement is lower for people who are most frail, indicating that different components of the 2 instruments may have greater relevance for people with advancing frailty in later life. There is a greater risk of ceiling effects using the EQ-5D-5L rather than the SF-6D.

Conclusions: We recommend the SF-36/SF-6D as an appropriate measure of health-related quality of life for clinical trials if fit older people are the planned target. In trials of interventions involving older people with increasing frailty, we recommend that both the EQ-5D-5L and SF36/SF6D are included, and are used in sensitivity analyses as part of cost-effectiveness evaluation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jval.2020.04.1830DOI Listing
August 2020

Self-management interventions to reduce healthcare use and improve quality of life among patients with asthma: systematic review and network meta-analysis.

BMJ 2020 08 18;370:m2521. Epub 2020 Aug 18.

National Institute for Health Research School for Primary Care Research, Manchester Academic Health Science Centre, University of Manchester, Manchester M13 9PL, UK.

Objective: To compare the different self-management models (multidisciplinary case management, regularly supported self-management, and minimally supported self-management) and self-monitoring models against usual care and education to determine which are most effective at reducing healthcare use and improving quality of life in asthma.

Design: Systematic review and network meta-analysis.

Data Sources: Medline, the Cochrane Library, CINAHL, EconLit, Embase, Health Economics Evaluations Database, NHS Economic Evaluation Database, PsycINFO, and ClinicalTrials.gov from January 2000 to April 2019.

Review Methods: Randomised controlled trials involving the different self-management models for asthma were included. The primary outcomes were healthcare use (hospital admission or emergency visit) and quality of life. Summary standardised mean differences (SMDs) and 95% credible intervals were estimated using bayesian network meta-analysis with random effects. Heterogeneity and publication bias were assessed.

Results: From 1178 citations, 105 trials comprising 27 767 participants were included. In terms of healthcare use, both multidisciplinary case management (SMD -0.18, 95% credible interval -0.32 to -0.05) and regularly supported self-management (-0.30, -0.46 to -0.15) were significantly better than usual care. For quality of life, only regularly supported self-management (SMD 0.54, 0.11 to 0.96) showed a statistically significant benefit compared with usual care. For trials including adolescents/children (age 5-18 years), only regularly supported self-management showed statistically significant benefits (healthcare use: SMD -0.21, -0.40 to -0.03; quality of life: 0.23, 0.03 to 0.48). Multidisciplinary case management (SMD -0.32, -0.50 to -0.16) and regularly supported self-management (-0.32, -0.53 to -0.11) were most effective at reducing healthcare use in patients with symptoms of severe asthma at baseline.

Conclusions: This network meta-analysis indicates that regularly supported self-management reduces the use of healthcare resources and improves quality of life across all levels of asthma severity. Future healthcare investments should provide support that offer reviews totalling at least two hours to establish self-management skills, reserving multidisciplinary case management for patients with complex disease.

Systematic Review Registration: PROSPERO number CRD42019121350.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmj.m2521DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7431958PMC
August 2020

Factors Associated With Burnout and Stress in Trainee Physicians: A Systematic Review and Meta-analysis.

JAMA Netw Open 2020 08 3;3(8):e2013761. Epub 2020 Aug 3.

National Institute for Health Research School for Primary Care Research, Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, United Kingdom.

Importance: Evidence suggests that physicians experience high levels of burnout and stress and that trainee physicians are a particularly high-risk group. Multiple workplace- and non-workplace-related factors have been identified in trainee physicians, but it is unclear which factors are most important in association with burnout and stress. Better understanding of the most critical factors could help inform the development of targeted interventions to reduce burnout and stress.

Objective: To estimate the association between different stressors and burnout/stress among physicians engaged in standard postgraduate training (ie, trainee physicians).

Data Sources: Medline, Embase, PsycINFO, and Cochrane Database of Systematic reviews from inception until April 30, 2019. Search terms included trainee, foundation year, registrar, resident, and intern.

Study Selection: Studies that reported associations between stressors and burnout/stress in trainee physicians.

Data Extraction And Synthesis: Two independent reviewers extracted the data and assessed the quality of the evidence. The main meta-analysis was followed by sensitivity analyses. All analyses were performed using random-effects models, and heterogeneity was quantified using the I2 statistic.

Main Outcome And Measures: The main outcome was the association between burnout/stress and workplace- or non-workplace-related factors reported as odds ratios (ORs) and their 95% CIs.

Results: Forty-eight studies were included in the meta-analysis (n = 36 266, median age, 29 years [range, 24.6-35.7 years]). One study did not specify participants' sex; of the total population, 18 781 participants (52%) were men. In particular, work demands of a trainee physician were associated with a nearly 3-fold increased odds for burnout/stress (OR, 2.84; 95% CI, 2.26-3.59), followed by concerns about patient care (OR, 2.35; 95% CI, 1.58-3.50), poor work environment (OR, 2.06; 95% CI, 1.57-2.70), and poor work-life balance (OR, 1.93; 95% CI, 1.53-2.44). Perceived/reported poor mental or physical health (OR, 2.41; 95% CI, 1.76-3.31), female sex (OR, 1.34; 95% CI, 1.20-1.50), financial worries (OR, 1.35; 95% CI, 1.07-1.72), and low self-efficacy (OR, 2.13; 95% CI, 1.31-3.46) were associated with increased odds for burnout/stress, whereas younger age and a more junior grade were not significantly associated.

Conclusions And Relevance: The findings of this study suggest that the odds ratios for burnout and stress in trainee physicians are higher than those for work-related factors compared with nonmodifiable and non-work-related factors, such as age and grade. These findings support the need for organizational interventions to mitigate burnout in trainee physicians.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jamanetworkopen.2020.13761DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7435345PMC
August 2020

What influences practitioners' readiness to deliver psychological interventions by telephone? A qualitative study of behaviour change using the Theoretical Domains Framework.

BMC Psychiatry 2020 07 16;20(1):371. Epub 2020 Jul 16.

School of Health Sciences, Division of Nursing, Midwifery and Social Work, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.

Background: Contemporary health policy is shifting towards remotely delivered care. A growing need to provide effective and accessible services, with maximal population reach has stimulated demand for flexible and efficient service models. The implementation of evidence-based practice has been slow, leaving many services ill equipped to respond to requests for non-face-to-face delivery. To address this translation gap, and provide empirically derived evidence to support large-scale practice change, our study aimed to explore practitioners' perspectives of the factors that enhance the delivery of a NICE-recommended psychological intervention, i.e. guided self-help by telephone (GSH-T), in routine care. We used the Theoretical Domains Framework (TDF) to analyse our data, identify essential behaviour change processes and encourage the successful implementation of remote working in clinical practice.

Method: Thirty-four psychological wellbeing practitioners (PWPs) from the UK NHS Improving Access to Psychological Therapies (IAPT) services were interviewed. Data were first analysed inductively, with codes cross-matched deductively to the TDF.

Results: Analysis identified barriers to the delivery, engagement and implementation of GSH-T, within eight domains from the TDF: (i) Deficits in practitioner knowledge, (ii) Sub-optimal practitioner telephone skills, (iii) Practitioners' lack of beliefs in telephone capabilities and self-confidence, (iv) Practitioners' negative beliefs about consequences, (v) Negative emotions, (vi) Professional role expectations (vii) Negative social influences, and (viii) Challenges in the environmental context and resources. A degree of interdependence was observed between the TDF domains, such that improvements in one domain were often reported to confer secondary advantages in another.

Conclusions: Multiple TDF domains emerge as relevant to improve delivery of GSH-T; and these domains are theoretically and practically interlinked. A multicomponent approach is recommended to facilitate the shift from in-person to telephone-based service delivery models, and prompt behaviour change at practitioner, patient and service levels. At a minimum, the development of practitioners' telephone skills, an increase in clients' awareness of telephone-based treatment, dilution of negative preconceptions about telephone treatment, and robust service level guidance and standards for implementation are required. This is the first study that provides clear direction on how to improve telephone delivery and optimise implementation, aligning with current mental health policy and service improvement.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12888-020-02761-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7364130PMC
July 2020

Community asset participation and social medicine increases qualities of life.

Soc Sci Med 2020 08 23;259:113149. Epub 2020 Jun 23.

Manchester Centre for Health Psychology, Division of Psychological Sciences and Mental Health, Coupland 1 Building, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.

Rationale: Social prescribing to community assets, like social groups, is a current policy goal. As aging adults lead longer, healthier lives, the effects of participating in community assets raises questions about whether subjective quality of life (QoL) improves during participation and on what dimensions.

Objective: The study's goal was to examine the effectiveness of community assets at improving QoL among older people living in the community.

Method: Examining longitudinal survey data which tracked health and wellbeing in older adults living in Salford, UK over 12 months, we first used regressions on community assets to compare the World Health Organization's QoL Assessment (WHOQOL-BREF) domains at baseline for those who already participated in community assets (54%) and with non-participants (46%). Second, we used propensity score matching to compare QoL in an 'uptake' group (no initial participation but who participated at 12 months), to those who never participated, and to a 'cessation' group who participated initially, but ceased within one year, to those who always participated.

Results: Group comparisons confirmed that participants reported significantly higher QoL on all domains - environmental, psychological, physical, and social QoL - and on 16 predicted facets. After affirming group matching reliability, the strongest results were for the uptake group, with significant improvements in all domains, and in 18 facets. All QoL domains decreased in the cessation group, but overall, the effect was weaker. As predicted from the context, QoL relating to 'opportunities for recreation and leisure' showed the greatest effect. Furthermore, QoL increased with uptake, and decreased with cessation.

Conclusion: Policies to improve QoL in later life should be designed not just to promote community assets, but also maintain participation once initiated.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.socscimed.2020.113149DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7397510PMC
August 2020

Is health research undertaken where the burden of disease is greatest? Observational study of geographical inequalities in recruitment to research in England 2013-2018.

BMC Med 2020 05 18;18(1):133. Epub 2020 May 18.

NIHR Clinical Research Network, University of Manchester, Manchester, UK.

Background: Research is fundamental to high-quality care, but concerns have been raised about whether health research is conducted in the populations most affected by high disease prevalence. Geographical distribution of research activity is important for many reasons. Recruitment is a major barrier to research delivery, and undertaking recruitment in areas of high prevalence could be more efficient. Regional variability exists in risk factors and outcomes, so research done in healthier populations may not generalise. Much applied health research evaluates interventions, and their impact may vary by context (including geography). Finally, fairness dictates that publically funded research should be accessible to all, so that benefits of participating can be fairly distributed. We explored whether recruitment of patients to health research is aligned with disease prevalence in England.

Methods: We measured disease prevalence using the Quality and Outcomes Framework in England (total long-term conditions, mental health and diabetes). We measured research activity using data from the NIHR Clinical Research Network. We presented descriptive data on geographical variation in recruitment rates. We explored associations between the recruitment rate and disease prevalence rate. We calculated the share of patient recruitment that would need to be redistributed to align recruitment with prevalence. We assessed whether associations between recruitment rate and disease prevalence varied between conditions, and over time.

Results: There was significant geographical variation in recruitment rates. When areas were ranked by disease prevalence, recruitment was not aligned with prevalence, with disproportionately low recruitment in areas with higher prevalence of total long-term and mental health conditions. At the level of 15 local networks, analyses suggested that around 12% of current recruitment activity would need to be redistributed to align with disease prevalence. Overall, alignment showed little change over time, but there was variation in the trends over time in individual conditions.

Conclusions: Geographical variations in recruitment do not reflect the suitability of the population for research. Indicators should be developed to assess the fit between research and need, and to allow assessment of interventions among funders, researchers and patients to encourage closer alignment between research activity and burden.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12916-020-01555-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7232839PMC
May 2020

Out of pocket expenses in obsessive compulsive disorder.

J Ment Health 2020 May 1:1-6. Epub 2020 May 1.

Institute of Psychiatry, Psychology & Neuroscience at King's College London, London, UK.

Despite anecdotal evidence that the out of pocket costs of OCD can be substantial in some cases, there is no evidence on how many people they affect, or the magnitude of these costs. This paper explores the type and quantity of out of pocket expenses reported by a large sample of adults with OCD. Data on out of pocket expenses were collected from participants taking part in the OCTET multi-centre randomised controlled trial. Participants were aged 18+, meeting DSM-IV criteria for OCD, and scoring 16+ on the Yale Brown Obsessive Compulsive Scale. Individual-level resource use data including a description and estimated cost of out of pocket expenses were measured using an adapted version of the Adult Service Use Schedule (AD-SUS): a questionnaire used to collect data on resource use. Forty-five percent (208/465) reported out of pocket expenses due to their OCD. The mean cost of out of pocket expenses was £19.19 per week (SD £27.56 SD), range £0.06-£224.00. Future economic evaluations involving participants with OCD should include out of pocket expenses, but careful consideration of alternative approaches to the collection and costing of this data is needed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/09638237.2020.1755028DOI Listing
May 2020
-->